Global Stability Senior Specialist (Remote)

Job Description

This is a remote role where we are flexible when it comes to the location.

Role responsibilities:

• Supports new product introductions by preparing the registration protocol and working with impacted sites on stability aspects of the program

• Prepares and approves technical responses to regulatory agency requests on pharmaceutical products.

• Performs and provides technical direction to sites, and global oversight groups on stability impact assessments in the change control system for process and stability changes

• Designs concise stability strategies, which meet all regulatory and technical needs to support post approval changes.

• Supports cross-functional investigation teams, conducts global assessments of the stability event, formulate recommendations, share outcomes with other impacted sites, and assist in assessing the need for global CAPA.

• Ensures that all consumer or distribution related stability inquiries are supported. Assesses stability data to establish appropriate categorizations for physician samples and product distribution. Assures proposed changes to label storage statements for market supply drug substances and drug products are aligned with available stability data and regulatory expectations.

• Ensures the accuracy and integrity of complex stability projects through second person reviews and approval of projects.

• Develops and revises departmental standard operating procedures (SOPs) and guidelines.

• Reviews regulatory documents for technical accuracy and compliance with agency expectations and internal guidance

• Performs statistical analysis to support stability decision, including but not limited to - shelf life changes and prediction of future results.

Role requirements:

• BS/MS/PhD in Chemistry or related science in a relevant discipline

• At least 5 years’ experience in the Pharmaceutical industry.

• Requires laboratory, regulatory or relevant experience and knowledge of cGMPs

• Requires superior written and oral communications skills.

• Proficient computer skills, and business/financial knowledge

• Ability to form good working relationships with other functional groups.

• Awareness of applicable agency regulations.

• Strong continuous improvement mindset with experience and skills in the tools.

• Requires established ability to achieve high productivity and ensure customer support, independently and/or in groups/team settings, by managing multiple projects/tasks simultaneously with competing priorities.

• Requires demonstrated resourcefulness, the ability to develop and implement innovative new concepts/ideas, the ability to effectively influence and negotiate, and the ability for managing and initiating change.

• Flexible working hours to cover global reach

About Organon:

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

Subject to applicable law, all prospective US Organon hires will be required to demonstrate that they have been fully vaccinated against COVID-19 with a vaccine authorized or approved by the Food and Drug Administration (FDA), or qualify for a medical or religious accommodation to this vaccination requirement, as a precondition of employment.

US and PR Residents Only

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com.

For more information about personal rights under Equal Employment Opportunity, visit:

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Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

Search Firm Representatives Please Read Carefully
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Salary Range

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R516942